Kornimate/medical-research-clean huggingface dataset:
effective dose of dexmedetomidine for sedation in patients undergoing turp/turb under spinal anesthesia with or without fentanyl by age groups: randomized comparative study

Conditions: Benign Prostate Hyperplasia; Bladder Tumor

Summary: recently many studies reported that intraoperative dexmedetomidine administration undergoing spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory depressions compared other sedatives(e.g. benzodiazepine) but the optimal dose of dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not got general consensus. the investigators hypothesized that the dose requirements would be lower than in elderly patients than young patients. furthermore, intrathecal small dose opioids enhance the analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of dexmedetomidine. the purpose of this study was to determine the dose of dexmedetomidine to provide satisfactory sedation undergoing spinal anesthesia with or without additive small dose intrathecal opioids. elderly patients(65\~85 years old) undergoing turp or turb were enrolled in this single-blinded study. forty patients were randomly assigned to receive intrathecal hyperbaric bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. after the induction (bilateral t10 sensory level to pinprick within 5 mins of intrathecal drug administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5, 0.4, 0.3, or 0.2mcg. successful sedation was defined as oass score 3 or 4 within 20 minutes of dexmedetomidine infusion. the dose of dexmedetomidine was selected for each patient according to an up and down method. intraoperative arterial pressure, heart rate, and bispectral index was compared. postoperative pain score, the time for the regression of sensory and motor was recorded for further analysis.


Eligibility criteria:
inclusion criteria: * elderly patients aged 65\~85 years olds undergoing turb or turp. * no contraindication of spinal anesthesia. * asa class i and ii. * patients consented to spinal anesthesia were enrolled. exclusion criteria: * patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias, and patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study.

Keywords: dexmedetomidine sedation in elderly patient spinal anesthesia
sublingual immunotherapy of birch pollen associated apple allergy

Conditions: Birch Pollen Related Apple Allergy; Birch Pollen Allergy

Summary: more than 70% of birch pollen allergic patients suffer from allergic reactions to certain foods, e.g. stone fruits, hazelnut and some vegetables. however, specific immunotherapy (sit) with birch pollen extract is not effective for the treatment of associated food allergy in a substantial number of patients. based on our previous clinical and immunological investigations of birch pollen related food allergy (bprfa) the investigators hypothesize that for effective sit of this abundant food allergy the disease-eliciting food allergens should be employed. to prove this concept, the investigators aim to sublingually administer the major apple allergen, mal d 1, to birch pollen-allergic patients with concomitant apple allergy and evaluate clinical and immunological effects of this treatment. the investigators choose mal d 1 as model food allergen because (i) its cross-reactivity with bet v 1 has been well characterized,(ii) apple is the most frequent trigger for bprfa and (iii) recombinant(r)mal d 1 was well tolerated after sublingual administration to 20 birch pollen-allergic patients in a previous study. sublingual administration of a defined concentration of gmp-rmal d 1 will be compared with equal doses of gmp-rbet v 1 as a positive control and placebo-treatment. clinical parameters will include skin prick tests (spt) and objective and subjective assessment of apple and birch pollen-induced allergic symptoms. immunological parameters will comprise the analysis of antibody and t cell responses to mal d 1 and bet v 1 as well as the evaluation of basophil activation. the proposed pilot study will be a first investigation of the concept to specifically treat bprfa with the involved food allergens and thus, represents an important step in the development of an efficient and safe therapy in the future.


Eligibility criteria:
inclusion criteria: * otherwise healthy persons between 18 und 50 years of age; * positive history of rhinoconjunctivitis to birch pollen * oral allergy syndrome(oas) to apple * positive skin prick test (spt) reaction to birch pollen and apple * specific ige for bet v 1 and mal d 1 exclusion criteria: * exclusion criteria * persons who due to their physical or mental state are not able to provide informed consent. * persons with underlying illnesses such as severe cardiopulmonary, malignant and/or autoimmune diseases * persons suffering from hyper-ige syndrome * persons receiving sit during the past 5 years * persons suffering from severe allergic reactions to apple such as generalized urticaria, asthma and/or anaphylaxis * persons suffering from severe bronchial asthma to birch pollen * persons suffering from pathological alterations of the lips and oral mucosa * persons who are prescribed a treatment with immune-suppressive drugs, anti-histamines, leukotriene-antagonists or psychotropic drugs with anti-histaminic effects * persons using ß-blockers * pregnant woman

Keywords: mal d 1, bet v 1, sublingual immunotherapy,
reducing dietary energy density by incorporating vegetables in order to decrease energy intake

Conditions: Obesity

Summary: this study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.


Eligibility criteria:
inclusion criteria: * healthy adults aged 20-45 years
prognostic hemodynamic and metabolic profiles of late stage lower extremity arterial disease

Conditions: Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)

Summary: late stage lower extremity arterial disease (lead) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. the prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group. current study aims to identify novel prognostic biomarkers for better risk stratification of late stage lead patients. it also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, micrornas) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.


Eligibility criteria:
exclusion criteria: * fontaine stage i-iia; * acute limb ischemia; * age \ 85 years; * fasting \< 6 hours; * time since the last use of tobacco products \< 4 hours; * body mass index ≥ 40 kg/m2 * blood pressure ≥ 180/120mmhg; * unstable angina; * atrial fibrillation at the time of presentation; * myocardial infarction, stroke or tia during the preceding 3 months; * any revascularization during the preceding 1 month; * severe heart failure (nyha iv); * clinically significant heart valve disease; * severe physical disability (other than limb ischemia); * acute infectious disease; * active malignancy or chemotherapy or disease-free \< 5 years; * type 1 diabetes; * uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine disorders; * moderate to severe asthma (gina 2016); * severe chronic obstructive pulmonary disease (mmrc grade 3-4) * acute (kdigo 2012) or chronic renal disease (egfr-epi \<30ml/min/1.73 m2); * clinically significant acute or chronic liver disease; * severe anemia (\<80 g/l); * clinically significant neuroinflammatory or neurodegenerative disease; * active rheumatism; * clinically significant connective tissue disease; * alcoholism or drug abuse; * psychotic disorders

Keywords: lower extremity arterial disease hemodynamics arterial stiffness metabolism metabolomics inflammation oxidative stress biomarkers prognosis
discriminant ability of the shock index, modified shock index, and reverse shock index multiplied by the glasgow coma scale on mortality in adult trauma patients: a patos study

Conditions: Trauma; Shock, Traumatic; Morality

Summary: we evaluated a cohort of adult trauma patients transported to emergency departments. the first vital signs were used to calculate the si, msi, and rsig. the areas under the receiver operating characteristic curves (aurocs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. a subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) ems-transported from january 2016 to december 2020 exclusion criteria: * patients with missing entries of age, sex, triage, sbp, dbp, hr, or gcs were excluded. * entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses. * patients without a modified rankin scale (mrs) record at discharge were excluded from the functional outcome cohort analyses.

Keywords: shock index(si) modified shock index (msi) reverse shock index multiplied by the glasgow coma scale (rsig) mortality pan-asian trauma outcomes study (patos)
open study of cep-701 in patients with refractory acute myeloid leukemia with flt-3 mutation

Conditions: Leukemia, Myeloid

Summary: the purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk aml expressing flt-3 activating mutations, when administered cep-701 at a dosage of 60 mg 2 times a day.

this is an open-label study of cep-701 in patients with refractory, relapsed, or poor risk aml expressing flt-3 activating mutations. patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.

Eligibility criteria:
inclusion criteria: * patient must have confirmed diagnosis of refractory or relapsed aml that expresses a flt-3 mutation * patient must have life expectancy of more than 2 months * patient must be fully recovered from reversible side effects of previous therapy for cancer exclusion criteria: * total bilirubin, alt or ast greater than 2 times upper limit of normal * patient \ 65 years of age with serum creatinine \> 1.5 times the upper limit of normal (uln) * received any investigational drug within past 4 weeks * gi disturbance/malabsorption that may affect absorption of cep-701 * hiv positive * received nsaid within prior 14 days * has active infection

Keywords: aml flt-3 mutation
a study of anterior approach combined with infrahepatic inferior vena cava clamping

Conditions: Surgical Approach & Incisions; Blood Loss

Summary: anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (hcc), but anterior approach has the problem of bleeding from the hepatic vein. our previous study showed that infrahepatic inferior vena cava (ivc) clamping can reduce blood loss during conventional hepatic resection. the investigators guess infrahepatic ivc clamping may also reduce blood loss in anterior approach right hepatic resection. so the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic ivc clamping and anterior approach in major right hepatectomy for large hcc.

traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. however, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (hcc) or for tumors with extrahepatic organ invasion in the right retrohepatic region.in setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.the anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.however,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein. bleeding from the hepatic veins is closely related to the cvp.our previous retrospective analysisfound that the infrahepatic inferior vena cava (ivc) clamping is efficacious in reducing cvp without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy. the aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic ivc clamping during right hepatectomy for large hcc reduces intraoperative blood loss.

Eligibility criteria:
inclusion criteria: * understanding and being willing to sign the informed consent form * aged 18-75 years * diagnosed hcc by clinical findings and radiography，tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three couinaud's segments) * without any surgery contraindication * child-pugh grade a exclusion criteria: * refusal to take part in the study * with lymph node or extrahepatic metastases * history of previous hepatectomy or other abdominal operation * those who can not be follow-up * non-hcc

Keywords: anterior approach infrahepatic inferior vena cava clamping hepatic resection
gastro-intestinal and hormonal responses to systemic inflammatory disease

Conditions: Motility Disorder; Catabolic State; Endotoxemia

Summary: the aim of this study is to describe hormonal responses and changes of the gastrointestinal (gi) tract during healthy and catabolic inflammatory conditions. participants will receive isocaloric, isonitrogenous beverages of either whey or 3-ohb+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).

background: endotoxemia (lps) is known to cause fever, inflammation and nausea, but the underlying mechanisms are unknown. in a human disease model comprising lps-induced inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms accounting for the nausea and decreased food intake often observed in hospitalized patients. aim: this study aims to investigate total transit time and motility of the gi-tract together with the regulation of gut- and appetite hormones following catabolic conditions compared with healthy controlled conditions hypothesis: catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces gi-tract and hormonal changes compared with healthy conditions (overnight fast) interventions: in a randomized crossover design, eight healthy, lean, young men will undergo either: i) healthy conditions (overnight fast) + whey protein ii) catabolic conditions (inflammation (lps) + 36-hour fast and bed rest\*) + whey protein iii) catabolic conditions (inflammation (lps) + 36-hour fast and bed rest\*) + 3-ketone/whey protein beverages will be isonitrogenous with 45 g whey protein + 20 g maltodextrin +/- 50 g of 3-ohb. bolus/sip administration will be applied (1/3 bolus, 2/3 sip).beverages will be isocaloric (fat will be added to interventions without 3-ohb) \*lps will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. on the study day lps (0.5 ng/kg) will be injected.

Eligibility criteria:
inclusion criteria: * between 20-40 years of age * body mass index between 20-30 kg/m\^2 * healthy * oral and written consent forms obtained prior to study day exclusion criteria: * recent immobilization of an extremity that is not fully rehabilitated * lactose, lidocain or rubber allergies * current disease * use of anabolic steroids * smoking former major abdominal surgery (or current problems with the gi tract) \>10 hours of exercise/weak present ketogenic diets or high-protein diets blood doner that does not want to discontinue blood donations until study completion pending mr scan

Keywords: gastric emptying gastro-intestinal motility endotoxemia catabolism glp-1 gip
the safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection

Conditions: Seizures; Meningioma

Summary: growing evidence of tranexamic acid (txa) being used to reduce blood loss and blood transfusions in various guidelines. however, the adverse effects of txa especially seizure has always been a problem of concern, especially in neurosurgery. therefore, this study aims to provide a scientific evidence for the safety of txa in supratentorial meningiomas resection patients.


Eligibility criteria:
inclusion criteria: * 1) age 18-80 years * 2) american society of anesthesiologist (asa) classification score i\~iii exclusion criteria: * 1) allergic to tranexamic acid * 2) preoperative seizures * 3) history of thrombotic disease * 4) chronic kidney disease * 5) breastfeeding or pregnancy * 6) refuse to participate in the study

Keywords: meningioma blood management
nose-close and abdomen-compression in pediatric flexible bronchoscopy

Conditions: Bradycardia; Hypoxemia

Summary: the nasopharyngeal oxygen (npo) with nose-close (nc) and abdomen-compression (ac) technique may use for support or rescue asphyxiated infants during flexible bronchoscopy.

objectives: to evaluate the efficacy of a novel cardiopulmonary resuscitation (cpr) technique-nasopharyngeal oxygenation with nose-close and abdomen-compression (npo-nc-ac)-in small infants during flexible bronchoscopy (fb). methods: infants with body weight (bw) \<5.0 kg and receiving nasal diagnostic or interventional fb (dfb, ifb) were enrolled. under npo (0.5 l/kg/min), when infant's heart rate (hr) \<80 beats/min or oxygen saturation (spo2) \<85% for more than 10 seconds, rescue nc-ac was initiated. it was performed by (1) increased npo flow to 0.5-1.0 l/kg/min; (2) nc 1 second for inspiration; and (3) ac 1 second for expiration with simultaneously released nostrils. repeat doing steps (2) and (3) at a rate of 30 cycles/min until hr, spo2, and blood pressure (bp) returned to normal. cardiopulmonary parameters were monitored and analyzed.

Eligibility criteria:
inclusion criteria: * body weight (bw) less than 5.0 kg; * receiving nasal approach flexible bronchoscopy. exclusion criteria: * cannot nasal approach flexible bronchoscopy.

Keywords: cpr flexible bronchoscope resuscitation ventilation
vascular changes due to different treatments of lymphedema secondary to postoperative breast cancer

Conditions: Breast Cancer; Lymphedema

Summary: the objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ecf) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer.

with increasing survival of women treated for breast cancer, it becomes necessary to evaluate the effect of therapeutic resources in morbidity due to surgical treatment of breast cancer. the objective of this study is to evaluate the effect of elastic compression, functional compressive bandaging (ecf) and active exercises in the bloodstream of the upper member ipsilateral to the surgical procedure for the treatment of breast cancer. the study will be conducted according to design random cross over and wash out period of 7 days. they will be evaluated 30 volunteers aged between 45 and 70 years, submitted to treatment of breast cancer. the volunteers will be submitted to three different therapeutic procedures applied randomly by lot: active exercises, functional compressive bandaging with active exercises and elastic compression with active exercises. the profile of blood flow, including speed and direction, will be assessed by doppler ultrasound before and after, at 0, 15, 30 minutes. normality will be verified by the shapiro-wilk test, and the effect of behavior between pre- and post-intervention will be evaluated by anova two-way followed by post-hoc test friedman followed rank, p \<0.05 . the data obtained in the study are intended to enhance the forms of physical therapy intervention in the face of circulatory morbidities resulting from breast cancer treatments.

Eligibility criteria:
inclusion criteria: * women diagnosed with breast cancer undergoing surgical treatment combined with axillary dissection or sentinel node biopsy * diagnosed with moderate to severe unilateral lymphedema exclusion criteria: * women with muscle-tendon injury and / or joint damage in the -affected limb, * skin disorders, * diabetes, * circulatory disease not controlled, -chemotherapy * radiotherapy, * diagnostic with metastasis in the upper limb * women pregnancy.

Keywords: blood circulation
a phase 1 clinical study of nxp900 in subjects with advanced cancers

Conditions: Advanced Solid Tumor

Summary: the purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of nxp900.

this is a dose escalation study of nxp900 administered to patients with advanced cancers. the study will propose dose and dose schedules for future studies.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent. 2. 18 years old or older. 3. advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the investigator. 4. measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1. 5. eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: 1. subjects with known human epidermal growth factor receptor 2 (her2+) overexpressing malignancies. 2. radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-c) of first dose of nxp900. subjects can continue to receive bisphosphonates due to metastatic bone disease or gnrh agonists if they have prostate cancer. 3. ongoing toxic manifestations of previous treatments \> grade 2 with the exception of alopecia and neuropathy. 4. subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (cns)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[mri\] or computed tomography \[ct\] scan) during the screening period. 5. female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception . 6. male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide). 7. major surgery from which the subject has not yet recovered.

Keywords: solid tumor carcinoma neoplasms adenocarcinoma